The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are: 1. Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery? 2. Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study? 3. Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)? Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery. The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
This study will investigate the effect of a preoperative mindfulness meditation intervention (MMI) on outcomes for total knee arthroplasty (TKA) patients at the Hospital for Special Surgery in a randomized controlled trial. Mindfulness meditation is a practice well-known to psychology research based on sustained attention on the present and a non-judgment of one's current situation. It has been used for numerous psychological issues including stress, anxiety, and depression. This intervention group will be compared against a waitlist control group (patients will be told they are on a waitlist to receive the mindfulness intervention, which will occur after data collection has finished for their group). This control has been utilized in several mindfulness meditation studies. Measures of anxiety, depression, resilience, pain and pain unpleasantness, and overall physical and mental health will be taken after randomization, but before the intervention (or being told they are on the waitlist). Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op. The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are: 1. Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery? 2. Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study? 3. Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)? Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery. The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
The mindfulness intervention is a scripted, \~12min audio recording based on core tenets of mindfulness meditation and contextualized for patients undergoing total knee arthroplasty. It teaches sustained attention on the present, body awareness, acceptance of the body's current state, and transformational strategies to cope with emotional or physical stimuli as they arise. It has been created by the study team based on the teachings of Jon Kabat Zinn (founder of mindfulness meditation) and the PI's history teaching yoga and meditation. Patients will be encouraged to review the audio recording once a week.
Hospital for Special Surgery
New York, New York, United States
Overall mental health score
PROMIS Mental Health Questionnaire is to assess general mental health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questionsare excellent, very good, good, fair, or poor.
Time frame: 1 week prior to surgery to post operative day 90
Anxiety
Generalized Anxiety Disorder Assessment (GAD-7) is used to assess severe anxiety in patients 1 Week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all sure, several days, over half the days, or nearly every day.
Time frame: 1 week prior to surgery to post operative day 90
Depression
The Patient Health Questionnaire (PHQ-9) is to assess depression in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are not at all, Several days, more than half the days, and nearly every day.
Time frame: 1 week prior to surgery to post operative day 90
Overall physical health scores
PROMIS Physical Health Questionnaire is used to assess general physical health in patients 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are excellent, very good, good, fair, or poor.
Time frame: 1 week prior to surgery to post operative day 90
Knee health
The KOOS-JR questionnaire will assess knee health after a total knee replacement surgery 1 week prior to surgery, post operative day 14, and post operative day 90. The responses to these questions are none, mild, moderate, severe, or extreme.
Time frame: 1 week prior to surgery to pre operative holding
MMI Practice Survey
The mindfulness meditation intervention practice survey helps to assess enrollment, retention, intervention completion and use measured by time to full enrollment, dropout number/proportion, number of MMI views/uses. The MMI practice survey is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. There are several different responses to these questions. These responses include yes or no; from 1-5+; emotional destress or physical pain; Not at all, somewhat improved, improved, or greatly improved.
Time frame: pre-operative holding to post-operative day 90
Exit Survey
The exit survey is used to assess ease and helpfulness of the mindfulness meditation intervention to the patients. This is asked to the intervention group in pre-operative holding, post-operative day 14 and post-operative day 90. This survey includes several different respnses to its questions. Responses include; open ended responses; yes or no; \< 1 week, 1-2 weeks, 3-4 weeks, or 4+ weeks.
Time frame: pre-operative holding to post-operative day 90
Pain outcomes of patients
The Pain Unpleasantness scale uses verbal descriptors to asses pain at 1 week prior to surgery, day of surgery, post-acute care unit (PACU), post operative day 14, and post operative day 90. The response to this questionnaire are slightly unpleasant, slightly annoying, unpleasant, annoying, slightly, distressing, very unpleasant, distressing, very annoying, slightly intolerable, very distressing, intolerable, or very intolerable.
Time frame: 1 week prior to surgery to post operative day 90
Numerical Rating Scale (NRS)
The NRS assesses pain levels on a scale from 0-10 in the operative knee 1 week prior to surgery, day of surgery, post-acute care unit (PACU), post operative day 14, and post operative day 90.
Time frame: 1 week prior to surgery to post operative day 90
Resilience training
The Brief Resilience Scale is used to assess the ability to recover from stress 1 Week prior to surgery, post operative day 14, and post operative day 90. The responses to this questionnaire are strongly agree, disagree, neutral, agree, strongly agree.
Time frame: 1 week prior to surgery to post operative day 90
Patient satisfaction
The patient satisfaction survey will assess patient satisfaction with results of the total knee replacement surgery taken on post operative day 14. The responses to this questionnaire range from 0-10, 0 being strongly dissatisfied and 10 being strongly satisfied.
Time frame: Post operative day 14
Pain catastrophizing scale
The pain catastrophizing scale assess pain experience and ability to cope with pain 1 week prior to surgery. The responses to this questionnaire are not at all, to a slight degree, to a moderate degree, to a great degree, or all the time.
Time frame: 1 week prior to surgery
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